Chronic DiseaseNCT02072941

Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)

A study testing PREPARE Intervention in people with Chronic Disease, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

In partnership with patients, caregivers, advocacy groups and clinicians, the investigators plan to: Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking Latinos and stakeholders. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Chronic Disease
What is being tested?: PREPARE Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 445 participants
Where: 1 siteUnited States
Study dates: Sep 2014to Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Spanish-speaking adults ≥ 55 years of age
≥ 2 chronic illnesses determined by ICD-9 codes
≥ 2 visits with an outpatient primary care clinician at San Francisco General hospital in the past year
≥ 2 additional outpatient/inpatient visits to San Francisco General Hospital in the past year

Who cannot join

Deaf, blind, demented or psychotic as determined by ICD-9 codes
Too mentally or physically ill to participate as determined by their clinicians
Moderate or severe cognitive impairment as determined by the Short Portable Mental Status Questionnaire (SPMSQ), and mild cognitive impairment by the SPMSQ plus an abnormal Mini-Cog (scores minimally affected by education/ethnicity)
Self-reported poor vision and inability to see the words on a newspaper
Lack of a telephone (for follow-up)
Traveling or moving out of the area for ≥3 months during the study follow-up period.

Trial locations and contacts

1 site in 1 country.

United States1 site

San Francisco General Hospital and Trauma Center
San Francisco, California, 94110

Other trials in United States

About this study

Official title: Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making

In partnership with patients, caregivers, advocacy groups and clinicians, the investigators plan to:

Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking Latinos and stakeholders.

Aim 2: Conduct a randomized clinical trial (RCT) to compare the efficacy of PREPARE plus a previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to:

2a. Engage older Spanish-speaking Latinos in multiple ACP behaviors (i.e., identify and discuss wishes with surrogates and clinicians and complete ADs) measured by self-report, chart review, surrogate reports, and

2b. Direct observation.

2c. Improve self-efficacy and satisfaction with medical decision making.

2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and clinician-patient language concordance.

Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.

Read the detailed description

PREPARE is a website (www.prepareforyourcare.org) that teaches patients how to identify what is most important in life, how to communicate their preferences to clinicians and loved ones, and how to make informed decisions. It is written at a 5th grade level and includes voice-overs of text and closed captioning of videos that model advance care planning behaviors. The goal of this proposal is to test the efficacy of PREPARE plus an easy-to-read advance directive, versus an advance directive alone, to improve patient engagement in multiple advance care planning behaviors including discussions with surrogate decision makers and clinicians in addition to advance directive completion. The investigators will also determine whether PREPARE can empower and activate patients within clinical encounters with their clinicians and help to decrease health disparities in advance care planning.

Conditions: Chronic Disease
Being tested: PREPARE Intervention
Keywords: Advance care planning, Latino Health, Medical decision making, Health Literacy, Limited English proficiency, Aging
Medical subject headings: Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PREPARE InterventionBehavioural
At week 1, 3, 6, and 12 months, interviews (telephone or in person based on preference) by blinded staff will assess engagement in advance care planning (ACP), self-efficacy with ACP, and activation in and satisfaction with decision making. Blinded telephone interviews will also assess surrogate reports of patient engagement in ACP.

Study groups in NCT02072941
Study group	Role	What they receive
PREPARE intervention	Experimental	The PREPARE arm will review the PREPARE website plus the easy-to-read advance directive (AD). Participants will review PREPARE on their own for ≥20 minutes with staff present to answer questions. During PREPARE, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning). To ensure home access to PREPARE content, participants will be given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD. One to three days before a primary care visit, the PREPARE arm will receive a reminder to come to their appointment and to bring their action plan. Receives: Behavioral: PREPARE Intervention
Control	No intervention	The control arm will review an easy-to-read AD. Controls will review the AD for ≥15 minutes with study staff present to answer questions and will take the AD home to complete if desired. One to three days before a primary care visit, controls will receive a reminder to come to their appointment.

What is being measured

The primary outcome is the main question the study is designed to answer.

New Advance Care Planning Documentation in the Medical Record at 15 Months
The primary outcome is documentation of advance care planning wishes in the medical record. ACP documentation for the purposes of this study includes the easy-to-read advance directive or other valid advance directives or living wills, a durable power of attorney for healthcare document (DPOAHC), a physicians orders for life sustaining treatment (POLST) form, or other documentation of patients wishes for medical care (ie, documentation of oral directives by a physician, or code status, such as full code or do not resuscitate or do not intubate orders or notes by a physician).
Measured: 15 months after study enrollment

Secondary outcomes (1)

Self-reported Engagement in Advance Care Planning Behaviors
Secondary outcomes were chosen to measure the full process of Advance Care Planning (ACP) using validated questionnaires, such as the patient-reported ACP Engagement Survey. This questionnaire includes both Behavior Change Process and ACP Action measures. Behavior Change Process measures include knowledge, contemplation, self-efficacy, and readiness for several ACP actions. The Process measures are assessed on an average 5-point Likert scale with a low of 1 and a high of 5, with high scores indicating more ACP engagement. Action measures include ACP actions such as identifying a surrogate decision-maker, identifying values and goals for medical care, choosing the level of leeway in surrogate decision-making, discussing one's wishes with clinicians and surrogates, and documenting one's wishes in an advance directive. Action measures use "yes" or "no" response options and are measured on a 0- to 25-point scale, where 0 is no action and 25 means they have engaged in more ACP actions.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Mar 2017

First posted27 Feb 2014 (estimated)
Study startSep 2014
Primary completionMar 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Chronic DiseaseStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 445 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02072941
Sponsor's protocol ID: P0061026
Other IDs: R-1306-01500
Status last verified: Apr 2019
First submitted: 24 Feb 2014
Last updated: 11 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gelfman LP, Barnes DE, Goldstein N, Volow AM, Shi Y, Li B, Sudore RL. Quality and Satisfaction With Advance Care Planning Conversations Among English- and Spanish-Speaking Older Adults. J Palliat Med. 2023 Oct;26(10):1380-1385. doi: 10.1089/jpm.2022.0565. Epub 2023 Jun 19.
PubMed 37335910
Freytag J, Street RL Jr, Barnes DE, Shi Y, Volow AM, Shim JK, Alexander SC, Sudore RL. Empowering Older Adults to Discuss Advance Care Planning During Clinical Visits: The PREPARE Randomized Trial. J Am Geriatr Soc. 2020 Jun;68(6):1210-1217. doi: 10.1111/jgs.16405. Epub 2020 Mar 10.
PubMed 32157684
Sudore RL, Schillinger D, Katen MT, Shi Y, Boscardin WJ, Osua S, Barnes DE. Engaging Diverse English- and Spanish-Speaking Older Adults in Advance Care Planning: The PREPARE Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1616-1625. doi: 10.1001/jamainternmed.2018.4657.
PubMed 30383086
Sudore RL, Barnes DE, Le GM, Ramos R, Osua SJ, Richardson SA, Boscardin J, Schillinger D. Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial. BMJ Open. 2016 Jul 11;6(7):e011705. doi: 10.1136/bmjopen-2016-011705.
PubMed 27401363

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making
ClinicalTrials.gov ID: NCT02072941
Acronym / sponsor ID: P0061026
Conditions: Chronic Disease
Keywords: Advance care planning, Latino Health, Medical decision making, Health Literacy, Limited English proficiency, Aging
Study type: Interventional
Recruitment status: Completed
Enrolment: 445 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: Sep 2014
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 27 Feb 2014 (estimated)
Results: Posted 11 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In partnership with patients, caregivers, advocacy groups and clinicians, the investigators plan to:

Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking Latinos and stakeholders.

Aim 2: Conduct a randomized clinical trial (RCT) to compare the efficacy of PREPARE plus a previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to:

2b. Direct observation.

2c. Improve self-efficacy and satisfaction with medical decision making.

2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and clinician-patient language concordance.

Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
PREPARE intervention	Experimental	Behavioral: PREPARE InterventionThe PREPARE arm will review the PREPARE website plus the easy-to-read advance directive (AD). Participants will review PREPARE on their own for ≥20 minutes with staff present to answer questions. During PREPARE, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning). To ensure home access to PREPARE content, participants will be given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD. One to three days before a primary care visit, the PREPARE arm will receive a reminder to come to their appointment and to bring their action plan.
Control	No intervention	–The control arm will review an easy-to-read AD. Controls will review the AD for ≥15 minutes with study staff present to answer questions and will take the AD home to complete if desired. One to three days before a primary care visit, controls will receive a reminder to come to their appointment.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Spanish-speaking adults ≥ 55 years of age
≥ 2 chronic illnesses determined by ICD-9 codes
≥ 2 visits with an outpatient primary care clinician at San Francisco General hospital in the past year
≥ 2 additional outpatient/inpatient visits to San Francisco General Hospital in the past year

Key exclusion criteria (6 listed)

Deaf, blind, demented or psychotic as determined by ICD-9 codes
Too mentally or physically ill to participate as determined by their clinicians
Moderate or severe cognitive impairment as determined by the Short Portable Mental Status Questionnaire (SPMSQ), and mild cognitive impairment by the SPMSQ plus an abnormal Mini-Cog (scores minimally affected by education/ethnicity)
Self-reported poor vision and inability to see the words on a newspaper
Lack of a telephone (for follow-up)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PREPARE InterventionAt week 1, 3, 6, and 12 months, interviews (telephone or in person based on preference) by blinded staff will assess engagement in advance care planning (ACP), self-efficacy with ACP, and activation in and satisfaction with decision making. Blinded telephone interviews will also assess surrogate reports of patient engagement in ACP.	Behavioural	PREPARE intervention

Primary outcome

New Advance Care Planning Documentation in the Medical Record at 15 Months
Time frame: 15 months after study enrollment
The primary outcome is documentation of advance care planning wishes in the medical record. ACP documentation for the purposes of this study includes the easy-to-read advance directive or other valid advance directives or living wills, a durable power of attorney for healthcare document (DPOAHC), a physicians orders for life sustaining treatment (POLST) form, or other documentation of patients wishes for medical care (ie, documentation of oral directives by a physician, or code status, such as full code or do not resuscitate or do not intubate orders or notes by a physician).

1 secondary outcome

Self-reported Engagement in Advance Care Planning Behaviors
Time frame: 12 months

Results and safety

Results posted to the registry on 11 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PREPARE Intervention	219	181
Control	226	197

Primary outcome: New Advance Care Planning Documentation in the Medical Record at 15 Months

Time frame: 15 months after study enrollment. Count of participants. Unit: Participants

Measure	PREPARE Intervention n = 219	Control n = 226
Value	83	58

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse even data were collected from the day of enrollment until completion of the 12-month follow-up interview.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PREPARE Intervention	0 of 219 (0%)	0 of 219 (0%)	3 of 219
Control	0 of 226 (0%)	0 of 226 (0%)	2 of 226

Limitations and caveats (from the sponsor): Participants could not be blinded. In addition, this study took place in one area of the country among Spanish-speaking, older patients who obtain care from safety-net settings. This may affect the generalizability of our findings.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37335910Gelfman LP, Barnes DE, Goldstein N, Volow AM, Shi Y, Li B, Sudore RL. Quality and Satisfaction With Advance Care Planning Conversations Among English- and Spanish-Speaking Older Adults. J Palliat Med. 2023 Oct;26(10):1380-1385. doi: 10.1089/jpm.2022.0565. Epub 2023 Jun 19.
Derived from this study: PubMed 32157684Freytag J, Street RL Jr, Barnes DE, Shi Y, Volow AM, Shim JK, Alexander SC, Sudore RL. Empowering Older Adults to Discuss Advance Care Planning During Clinical Visits: The PREPARE Randomized Trial. J Am Geriatr Soc. 2020 Jun;68(6):1210-1217. doi: 10.1111/jgs.16405. Epub 2020 Mar 10.
Derived from this study: PubMed 30383086Sudore RL, Schillinger D, Katen MT, Shi Y, Boscardin WJ, Osua S, Barnes DE. Engaging Diverse English- and Spanish-Speaking Older Adults in Advance Care Planning: The PREPARE Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1616-1625. doi: 10.1001/jamainternmed.2018.4657.
Derived from this study: PubMed 27401363Sudore RL, Barnes DE, Le GM, Ramos R, Osua SJ, Richardson SA, Boscardin J, Schillinger D. Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial. BMJ Open. 2016 Jul 11;6(7):e011705. doi: 10.1136/bmjopen-2016-011705.
PREPARELink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rebecca Sudore, MD principal investigator

University of California, San Francisco

Dean Schillinger, MD principal investigator

University of California, San Francisco

Deborah E Barnes, PhD principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PREPARE Intervention in people with Chronic Disease, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New Advance Care Planning Documentation in the Medical Record at 15 Months (time frame: 15 months after study enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02072941, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.